GVS advice baloxavir marboxil (Xofluza®)
The National Health Care Institute has completed its assessment whether the product baloxavir marboxil (Xofluza®) is interchangeable with a product that is included in the Medicine Reimbursement System (GVS). Baloxavir marboxil is indicated for the treatment of patients with influenza. This is a medical term for the flu. The National Health Care Institute advises the Minister to not include baloxavir marboxil in the GVS.
Indication for which reimbursement is requested
Baloxavir marboxil is indicated for the treatment of uncomplicated influenza in patients aged 12 years and above and for the post-exposure prophylaxis of influenza in individuals aged 12 and above.
Outcome of the substantive assessment
For baloxavir marboxil in the treatment of uncomplicated influenza in patients aged 12 years and above who are eligible for annual flu vaccination, no significant added value has been demonstrated above normal care (paracetamol, antibiotics) or oseltamivir. No clinically relevant benefit of baloxavir marboxil has been demonstrated on the crucial outcome parameters of survival, hospitalisation and complications (defined as pneumonia, myocarditis and pericarditis).
The National Health Care Institute's advice
On the basis of the considerations mentioned above, the National Health Care Institute recommends that baloxavir marboxil should not be included in the GVS.